A Double-Blind, Placebo Controlled Trial of an Experimental Medication For the Treatment of Generalized Anxiety Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 511
- 试验地点
- 99
- 主要终点
- Change in HAM-A Total Score
研究概览
简要总结
The purpose of this study is to determine whether an experimental anti-anxiety medication is effective in the treatment of Generalized Anxiety Disorder.
详细描述
Protocol 04-001-01
The primary objective of the study is to assess, under controlled conditions, the safety and efficacy of an experimental anti-anxiety medication relative to placebo in subjects with generalized anxiety disorder (GAD).
The secondary objective of the study is to study algorithms for discontinuation of an experimental anti-anxiety medication.
Recruiting: Participants are currently being recruited and enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 18 to 65 years of age will be eligible to participate if they satisfy the DSM-IV-TR criteria for the diagnosis of GAD.
排除标准
- •No other primary psychiatric diagnosis besides GAD.
结局指标
主要结局
Change in HAM-A Total Score
时间窗: Baseline to week 8
Hamilton Anxiety Rating Scale (HAM-A). Each of 14 symptoms categories is rated from 0=not present to 4=very severe. Numbers for all categories are summed to produce the total score. Total score ranges from 0=anxiety symptoms not present to 56=very severe anxiety symptoms across all 14 categories.
次要结局
未报告次要终点